MAUDE Adverse Event Report: NURSEL BOELENS HEATER COOLER UNIT HCU 30; CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS

Model Number HCU 30

Device Problems Insufficient Heating (1287); Temperature Problem (3022)

Patient Problem No Patient Involvement (2645)

Event Date 11/19/2020

Event Type  malfunction  

Manufacturer Narrative

The hcu 30 showed the error ¿1004-2 main heater temp.Sensor error¿.According to the "describe event of problem" grid the getinge field service technician (fst) removed the actuator from 3 way valve.The fst cleaned 3 way valve pin and did lubrication, after that the actuator was reconnected.The most probable root cause for the reported failure was the malfunction of the 3 way valve.No more failure was detected.Function tests all passed.Similar failure "error 1004" was already investigated in a similar complaint no.(b)(4) on 2014-10-02 with life cycle engineering (lce) investigation report no.(b)(4): the most probable root cause of the reported malfunction is a slight oxidation layer is inside the 3-way valve.The occurrence rate was calculated for the reported issue and it was determined that this is not a systemic issue.Therefore, no remedial action is required.The review of the non-conformities during the period of 2010-10-08 to 2020-11-30 does not show any non-conformity in regard to the reported product and failure.Thus the reported failure "error 1004-2" could be confirmed.It is unknown when the event occurred, was the device being used for treatment or diagnosis of the patient.The hcu 30 which was used, was responsible for this complaint.The occurrence rate related to the reported issue is currently being monitored as part of maquet cardiopulmonary¿s trending program and additional investigations or corrections will be implemented in case of adverse trending.

Event Description

Complaint # (b)(4): it was reported that the hcu 30 showed the error ¿1004-2 main heater temp.Sensor error¿.

• Brand Name: HEATER COOLER UNIT HCU 30
• Type of Device: CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
• Manufacturer (Section G): NURSEL BOELENS; maquet cardiopulmonary ag; kehler strasse 31; rastatt 76437 ; GM 76437
• Manufacturer Contact: maquet cardiopulmonary ag; kehler strasse 31; rastatt 76437 ; 4972229321
• MDR Report Key: 10934028
• MDR Text Key: 219174419
• Report Number: 8010762-2020-00416
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K031544
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HCU 30
• Device Catalogue Number: 70103.4642
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 11/19/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/08/2010
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1